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The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation | Clinical Trials | Clareo Health

TERMINATEDNA

The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation

The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation

NCT04626427•C. R. Bard

View on ClinicalTrials.gov

Summary

This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in patients who require a vascular access for hemodialysis (HD).

Detailed Description

The purpose of this clinical investigation is to provide clinical evidence to further demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ EndoAVF System when used for endovascular arteriovenous fistula (endoAVF) creations. Treated participants will be followed for 24-months post index procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The participant must:
•1. Be able to comprehend, voluntarily sign and date the informed consent form (ICF) prior to collection of clinical investigation data or performance of clinical investigation procedures (or where allowable the participant's legally authorized representative (LAR) on behalf of the participant).
•2. Be able to and willing to comply with the CIP requirements, including clinical follow-up.
•3. Be male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient (≥ 24 months) to allow for completion of all clinical investigation procedures.
•4. Have established, non-reversible kidney failure, who are currently on HD at screening or are in need of a vascular access for HD as determined by the referring clinician.
•5. Target treatment vein diameter(s) for AVF creation ≥ 2.0 mm as measured via DUS or angiography.
•6. A target treatment artery diameter ≥ 2.0 mm as measured via DUS or angiography.
•7. Adequate collateral circulation to the hand, in the opinion of the Principal Investigator (PI) (or authorized designee).
•8. At least one superficial outflow vein diameter ≥ 2.5 mm as measured via DUS or angiography that is in communication with the target creation site via a proximal forearm perforating vein.

Exclusion Criteria

•The participant must not have:
•1. Active or nontreated hypercoagulable state.
•2. Known bleeding diathesis.
•3. Insufficient cardiac output to support the maturation and use of an AVF in the opinion of the PI (or authorized designee).
•4. Known history of or current active intravenous drug abuse.
•5. A "planned" major surgical procedure within 6 months following index procedure or major surgery, in the opinion of the PI (or authorized designee), within 30 days prior to index procedure.
•6. Known allergy or hypersensitivity to contrast media which cannot be adequately treated with pre-medication.
•7. Known adverse effects to sedation and / or anesthesia which cannot be adequately treated with pre-medication.
•8. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and / or White Blood Cell (WBC) Count of ≥ 12,000 cells / μL, if collected).
•9. Another medical condition, which, in the opinion of the PI (or authorized designee), may cause him / her to be non-compliant with the CIP, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of clinical investigation procedures and follow-up.
+6 more criteria

Locations (3)

Imelda Hospital Bonheiden

Bonheiden, Belgium

University Hospital of Patras "Panagia I Voitheia"

Rio, Greece

Kantonsspital Winterthur

Winterthur, Switzerland

Key Dates

Start Date

December 23, 2020

Primary Completion Date

June 15, 2022

Completion Date

June 15, 2022

Last Updated

January 16, 2025

Enrollment

ACTUAL participants

Conditions

End Stage Kidney DiseaseChronic Kidney DiseasesKidney FailureKidney InsufficiencyKidney Disease, ChronicAV FistulaFistulas Arteriovenous

Interventions

WavelinQ™ EndoAVF System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation

Inclusion Criteria

Exclusion Criteria

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